Identity
- Trade Name
- Flexcoil Comfort Module VR EUDAMED
- Device Name
- Comfort Modules EUDAMED
- Model / Reference
- P10107-669 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120074396692 EUDAMED
- Basic UDI-DI
- 91200743926M5 EUDAMED
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Flexcoil Comfort Module VR by IT-V Medizintechnik GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 91200743926M5 | Class I | Active |
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Manufacturer
- Manufacturer
- IT-V Medizintechnik GmbH
- EUDAMED SRN
- AT-MF-000001918
Sources (1)
- EUDAMED 86122eaa-4c1a-4415-9f58-5a5292291d63 61 fields · synced Jun 19, 2026